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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-1214

2. Registrant Information.

Registrant Reference Number: M-800905-01-1

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: Suite 200, 160 Quarry Park Boulevard SE

City: CALGARY

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

3. Select the appropriate subform(s) for the incident.

Scientific Study

4. Date registrant was first informed of the incident.

5. Location of incident.

6. Date incident was first observed.

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

PMRA Registration No. 19204      PMRA Submission No.       EPA Registration No.

Product Name: Phenmedipham TC

• Active Ingredient(s)
  • PHENMEDIPHAM

7. b) Type of formulation.

Application Information

8. Product was applied?

Unknown

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform VII: Scientific Study

1. Study Reference

Title Phenmedipham: Fish Short-Term Reproduction Assay with the FatheadMinnow (Pimephales promelas)

Date 31-JAN-22

2. a) Is an extension needed to translate the document?

No

3. Type of incident identified in the study

New health or environmental hazard

4. Describe the incident identified in the study (e.g. study demonstrates an increased risk to non-Hodgkin's Lymphoma after exposure to pesticide X)

Statistical analysis concluded that there was a treatment-related effect observed on fecundity, in terms of the cumulative number of eggs produced and the number of eggs produced per female per reproductive day, at the 0.176 mg phenmedipham+MHPC/L (0.0956 mg phenmedipham/L) treatment level compared to the control. This appears to be lower than the current chronic 28-day fish LOEC for fry survival (0.181 mg phenmedipham+MHPC/L), thus would meet the criteria for adverse effects reporting [Matlock, et. al. 2014; Early Life Stage Toxicity of Phenmedipham to the Rainbow Trout (Oncorhynchus mykiss) Under Flow-Through Conditions]. However, this study is not considered appropriate for assessing chronic risk to fish for 2 reasons. First, this study is an endocrine screening study. Second, there are a limited number of test concentrations employed and a specific dose-spacing factor and these constraints do not provide for the type of dose-response analysis that lends to a robust risk assessment endpoint.

5. a) Was the study discontinued before completion?

No

5. b) Provide the reason for discontinuation

6. If the study is ongoing, what is the expected completion date?

For Registrant use only

7. Provide supplemental information here

The fish short-term reproduction assay was conducted to meet endocrine testing requirements for active ingredients in the European Union. The study met reportability criteria under Canadian adverse effects reporting guidelines.